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Pentec Health

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-581-2013Class IIProplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterilMay 15, 2013
D-584-2013Class IIFresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added aMay 15, 2013
D-592-2013Class IIProplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acidMay 15, 2013
D-588-2013Class IIProplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids)May 15, 2013
D-582-2013Class IIBaxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with addMay 15, 2013
D-595-2013Class IIBaxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added aMay 15, 2013
D-585-2013Class IIIDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag,May 15, 2013
D-583-2013Class IIBaxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added aMay 15, 2013
D-590-2013Class IIProplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), May 15, 2013
D-589-2013Class IIProplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), May 15, 2013
D-586-2013Class IIProplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids)May 15, 2013
D-594-2013Class IIBaxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with addedMay 15, 2013
D-591-2013Class IIProplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), May 15, 2013
D-593-2013Class IIBaxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with aMay 15, 2013
D-587-2013Class IIProplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids)May 15, 2013